Submitting DSEN Queries

What is a DSEN Query

A DSEN Query is a focused, well defined question identified by healthcare decision-makers, resulting from a gap in evidence on the safety and effectiveness of prescribed drugs on the Canadian market; and, that can be addressed through DSEN sponsored research.

Scope

DSEN is presently focussed on the safety and effectiveness of Prescription Drugs (biologics and pharmaceuticals) used in the real-world. Over-the-counter Drugs, Medical Devices and Natural Health Products (including vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, and other products such as amino acids and essential fatty acids) are presently not addressed under DSEN's mandate.

Eligibility

At present, DSEN Queries are those potential research questions submitted by high level decision makers working within the Federal Regulator, a Federal, Provincial or Territorial (F/P/T) drug plan or an organization mandated to support F/P/T decision making with respect to drugs.

Stakeholders with a potential DSEN research question should complete, to the best of their ability, the template "DSEN Query Summary", identifying the various elements of the issue(s) relating to their DSEN research question.

The table below identifies the parties who are eligible as well as ineligible to submit DSEN Queries.

Eligible parties Ineligible parties
  • Federal regulator
  • F/P/T drug plan
  • Organizations mandated to support F/P/T decision making with respect to drugs (e.g. CADTH)
  • Voluntary Health Organizations
  • For profit enterprises (e.g. drug manufacturers, private insurance providers)
  • Individual practitioners
  • Community pharmacies
  • Public (e.g. patients, advocacy or consumer organizations)

Process

DSEN has two documents available, which provide a description of the management processes of the DSEN Queries and guidance to assist stakeholders in submitting Queries.

Framework for the Management of DSEN Queries

The Framework describes the processes used for the management of DSEN Queries into the safety and effectiveness of drugs on the Canadian market. The management of these DSEN Queries involves steps and elements for the identification and submission of the queries, as well as the feasibility assessment, prioritization, research and knowledge translation.

Guidance Document for Submitters of DSEN Queries

This guidance document has been prepared to assist stakeholders in submitting DSEN Queries for prioritization by the DSEN Steering Committee. It provides an overview on the process and makes tools available in the form of standardized procedures and templates.

Template "DSEN Query Summary" for submission of DSEN Query [ Fillable PDF (62 KB) ] (A Word version is available upon request to DSEN-RIEM@cihr-irsc.gc.ca).